Feasibility of the A-STEP for the assessment of exercise capacity in people with cystic fibrosis.

OBJECTIVES: To evaluate feasibility of the Alfred Step Test Exercise Protocol (A-STEP) for the assessment of exercise capacity in adults and children with cystic fibrosis (CF); in adults to test whether demographics and/or lung function correlated with exercise capacity. METHODS: Adults and children with stable CF from two centres completed the A-STEP (a recently developed incremental maximal-effort step test). Feasibility was evaluated by: usefulness for exercise capacity assessment (measures of exercise capacity were: level reached, exercise-induced desaturation, and achievement of at least one maximal effort criteria); safety; operational factors; time to complete; floor and/or ceiling effects. We used multiple linear regression to test whether demographics and/or lung function correlated with exercise capacity. RESULTS: A total of 49 participants: 38 adults (18 male), percent predicted (pp) forced expiration in one second (FEV1 ) 29-109, aged 22-48 years and 11 children (6 male), ppFEV1 68-107, aged 10-15 years were included. Levels reached (mean (SD) [range]) were 10.2 (2.4) [6-15] (adults), 10.1 (2.5) [7-14] (children); desaturation (change between baseline and peak-exercise SpO2 ): was 8.4 (3.8 [0-15]% (adults), 2.0 (2.0) [0-7]% (children). A total of 8 (21%) adults and no children desaturated <90% SpO2 . At least one criterion for maximal effort was reached by 33 (84%) adults and 10 (91%) children. There were no adverse events. The A-STEP was straightforward to use and carried out by one operator. A total of 26 (68.4%) adults and 7 (63.6%) children completed the test within the recommended 8-12 min. All participants completed a minimum of 6 levels, and completed the test before the final 16th level. In adults, ppFEV1 and ppFVC correlated with the level reached (r = 0.55; p = <0.001 and r = 0.66, p = <0.0001) and desaturation (r = 0.55, p = <0.001 and r = 0.45, p = <0.005). CONCLUSION: In adults and children with stable CF, the A-STEP was feasible, safe, and operationally easy to use for the assessment of exercise capacity, without floor or ceiling effects. In adults, lung function correlated with exercise capacity.

Development and pilot test of a process to identify research needs from a systematic review.

OBJECTIVE: To ensure appropriate allocation of research funds, we need methods for identifying high-priority research needs. We developed and pilot tested a process to identify needs for primary clinical research using a systematic review in gestational diabetes mellitus. STUDY DESIGN AND SETTING: We conducted eight steps: abstract research gaps from a systematic review using the Population, Intervention, Comparison, Outcomes, and Settings (PICOS) framework; solicit feedback from the review authors; translate gaps into researchable questions using the PICOS framework; solicit feedback from multidisciplinary stakeholders at our institution; establish consensus among multidisciplinary external stakeholders on the importance of the research questions using the Delphi method; prioritize outcomes; develop conceptual models to highlight research needs; and evaluate the process. RESULTS: We identified 19 research questions. During the Delphi method, external stakeholders established consensus for 16 of these 19 questions (15 with "high" and 1 with "medium" clinical benefit/importance). CONCLUSION: We pilot tested an eight-step process to identify clinically important research needs. Before wider application of this process, it should be tested using systematic reviews of other diseases. Further evaluation should include assessment of the usefulness of the research needs generated using this process for primary researchers and funders.

Impact of tobacco control interventions on smoking initiation, cessation, and prevalence: a systematic review.

BACKGROUND: Policymakers need estimates of the impact of tobacco control (TC) policies to set priorities and targets for reducing tobacco use. We systematically reviewed the independent effects of TC policies on smoking behavior. METHODS: We searched MEDLINE (through January 2012) and EMBASE and other databases through February 2009, looking for studies published after 1989 in any language that assessed the effects of each TC intervention on smoking prevalence, initiation, cessation, or price participation elasticity. Paired reviewers extracted data from studies that isolated the impact of a single TC intervention. FINDINGS: We included 84 studies. The strength of evidence quantifying the independent effect on smoking prevalence was high for increasing tobacco prices and moderate for smoking bans in public places and antitobacco mass media campaigns. Limited direct evidence was available to quantify the effects of health warning labels and bans on advertising and sponsorship. Studies were too heterogeneous to pool effect estimates. INTERPRETATIONS: We found evidence of an independent effect for several TC policies on smoking prevalence. However, we could not derive precise estimates of the effects across different settings because of variability in the characteristics of the intervention, level of policy enforcement, and underlying tobacco control environment.

Therapeutic management, delivery, and postpartum risk assessment and screening in gestational diabetes.

OBJECTIVES: We focused on four questions: What are the risks and benefits of an oral diabetes agent (i.e., glyburide), as compared to all types of insulin, for gestational diabetes? What is the evidence that elective labor induction, cesarean delivery, or timing of induction is associated with benefits or harm to the mother and neonate? What risk factors are associated with the development of type 2 diabetes after gestational diabetes? What are the performance characteristics of diagnostic tests for type 2 diabetes in women with gestational diabetes? DATA SOURCES: We searched electronic databases for studies published through January 2007. Additional articles were identified by searching the table of contents of 13 journals for relevant citations from August 2006 to January 2007 and reviewing the references in eligible articles and selected review articles. REVIEW METHODS: Paired investigators reviewed abstracts and full articles. We included studies that were written in English, reported on human subjects, contained original data, and evaluated women with appropriately diagnosed gestational diabetes. Paired reviewers performed serial abstraction of data from each eligible study. Study quality was assessed independently by each reviewer. RESULTS: The search identified 45 relevant articles. The evidence indicated that: Maternal glucose levels do not differ substantially in those treated with insulin versus insulin analogues or oral agents. Average infant birth weight may be lower in mothers treated with insulin than with glyburide. Induction at 38 weeks may reduce the macrosomia rate, with no increase in cesarean delivery rates. Anthropometric measures, fasting blood glucose (FBG), and 2-hour glucose value are the strongest risk factors associated with development of type 2 diabetes. FBG had high specificity, but variable sensitivity, when compared to the 75-gm oral glucose tolerance test (OGTT) in the diagnosis of type 2 diabetes after delivery. CONCLUSIONS: The evidence suggests that benefits and a low likelihood of harm are associated with the treatment of gestational diabetes with an oral diabetes agent or insulin. The effect of induction or elective cesarean on outcomes is unclear. The evidence is consistent that anthropometry identifies women at risk of developing subsequent type 2 diabetes; however, no evidence suggested the FBG out-performs the 75-gm OGTT in diagnosing type 2 diabetes after delivery.

The reported validity and reliability of methods for evaluating continuing medical education: a systematic review.

PURPOSE: To appraise the reported validity and reliability of evaluation methods used in high-quality trials of continuing medical education (CME). METHOD: The authors conducted a systematic review (1981 to February 2006) by hand-searching key journals and searching electronic databases. Eligible articles studied CME effectiveness using randomized controlled trials or historic/concurrent comparison designs, were conducted in the United States or Canada, were written in English, and involved at least 15 physicians. Sequential double review was conducted for data abstraction, using a traditional approach to validity and reliability. RESULTS: Of 136 eligible articles, 47 (34.6%) reported the validity or reliability of at least one evaluation method, for a total of 62 methods; 31 methods were drawn from previous sources. The most common targeted outcome was practice behavior (21 methods). Validity was reported for 31 evaluation methods, including content (16), concurrent criterion (8), predictive criterion (1), and construct (5) validity. Reliability was reported for 44 evaluation methods, including internal consistency (20), interrater (16), intrarater (2), equivalence (4), and test-retest (5) reliability. When reported, statistical tests yielded modest evidence of validity and reliability. Translated to the contemporary classification approach, our data indicate that reporting about internal structure validity exceeded reporting about other categories of validity evidence. CONCLUSIONS: The evidence for CME effectiveness is limited by weaknesses in the reported validity and reliability of evaluation methods. Educators should devote more attention to the development and reporting of high-quality CME evaluation methods and to emerging guidelines for establishing the validity of CME evaluation methods.